President, Rajamani Group, LLC, Milltown, NJ, USA
Raj is the President of “Rajamani Group, LLC” and is a Quality Assurance and Compliance Professional with expertise and a proven record of success in the Design and Implementation of Quality Systems and Manufacturing Systems. Raj has more than 40 years of industry experience and has worked in pharmaceutical research, development, and formulation, pharmaceutical and biotech production, project and process engineering, validation and process automation for Pharmaceutical, Biotech, Cosmetics, and Dietary Supplements products during his career at Pfizer Inc. NY, GSK (SmithKline Beecham), Baxter International, BMS (Squibb), Union Carbide, France, Italy, and Belgium Atomic Energy Consortium. He is presently providing consulting services to major Pharmaceutical, Biotechnology, Medical Device, Cosmetics, and Dietary Supplements companies globally in all areas of regulatory and cGMP compliance. Raj retired from Pfizer Inc. on January 1, 2011. Between 2011 and 2018, as an independent consultant, Raj routinely provided consulting services to Pharmaceutical (FDA 21 CFR 2010/211, EU cGMPs, WHO, and India GMPs), Biotech, Dietary Supplements (21 CFR Part 111), and Cosmetic Industries (ISO 22716:2077 & FDA Cosmetic Guidance) in Quality and Manufacturing Management Systems; Supplier Quality Management, Audits, Risk Assessments, Due Diligence; Regulatory, Quality and Compliance gap analysis; Deviation & CAPA Investigations; Validations; Remediation; Regulatory Inspection & PAI readiness supporting Manufacturing, Quality and Regulatory compliance. Raj is the past Chairman of the American Society for Quality (ASQ NEI Section) and served as an Officer or Director, and a member of the editorial advisory board of American Pharmaceutical Outsourcing. Author and frequent speaker about quality management systems (QMS), FDA/EU/WHO Pre- Approval Inspection (PAI) & Regulatory Inspections, and regulatory compliance in pharmaceutical and biotech industry. Raj was a Global Health fellow in Christian Medical College Hospital in Vellore, South India. For this work, he was nominated and awarded the Golden Apple Award by the Health Volunteers Overseas (NGO) in 2007 and 2012. Raj also served as a Scientific and Technical Advisor to the Board of Chakra Biosciences USA. He is presently serving as a Foundation Member in the Vellore Christian Medical College Foundation (USA), Inc.